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'Substantial Growth' Led This Lab to Replace its Testing Systems With Next-Generation Platforms

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NEW YORK – In the midst of "substantial growth" Ascend Clinical Laboratory decided it needed to replace its existing Siemens Healthineers immunoassay analyzers with newer systems.

In March, it did so, completing installation of the Siemens Healthineers next generation of analyzers, the Atellica IM 1600, to replace the Advia Centaur XPT, which Ascend was already using. So far, the switch has resulted in greater testing efficiencies and management of increased testing demand, Andrew Fountaine, manager of immunochemistry testing at the Redwood City-based lab, told 360Dx.

Among the most important benefits realized thus far is a doubling of instrument capacity and with it the capability to double testing volume within the same physical space, he said.

Fountaine presented the first details associated with Ascend's Atellica installation in August during the American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo in Anaheim, California.

Ascend's laboratory conducts testing for more than 2,000 clinics and completes several million tests overall per year. It uses mostly Beckman Coulter analyzers for clinical chemistry and Sysmex analyzers for hematology testing. The immunology testing department that Fountaine manages uses only Siemens immunoassay analyzers, and conducts at least 2 million tests during a 12-month period, he said recently in a followup interview.

Among other tests, the lab frequently runs immunoassays for thyroid function and measures levels of infectious disease markers, including for hepatitis B, hepatitis C, and HIV. The mix of tests that the lab completes have remained roughly the same for the past several years, but its lab executives realized that it needed a more advanced system, especially to manage demand during peak periods, Fountaine said during an interview.

Prior to implementing the Atellica line of immunoassay analyzers, the immunology lab at Ascend had experienced "some difficulties during [its] highest volume periods," he said, adding that at the same time, the lab "also wanted to be able to accommodate [anticipated] growth within the next few years."

In particular, he said, the lab was seeing an uptick in demand from the independent, end-stage dialysis clinics that it serves throughout the US.

In addition to evaluating the Atellica Solution portfolio of immunoassay systems, Ascend researched other instruments in the year prior to selecting Atellica, "but they just did not compare to what was being advertised with Atellica," Fountaine said. Further, Ascend has been a long-time Siemens immunoassay user, and its selection of the Atellica was "very straightforward knowing how well their earlier immunoassay analyzers worked" for them.

To meet testing demand, Ascend selected five Atellica Solution systems, each with two immunoassay modules.

However, implementing any kind of diagnostic system at this scale comes with its challenges, he noted. "One of the largest factors to consider is space and how you are going to fit the instrumentation into that space, as well as the utility associated with the instrumentation," he said. "There are always going to be some unknowns," and one of the main questions is how well the new system will operate during times of high stress, when it will need high throughput.

When Ascend began installing the Atellica immunoassay analyzers in its laboratory, the equipment initially had about half the menu of assays that were available on the XPT system, Fountaine said.

That required a leap of faith with Siemens, its diagnostic system supplier. "Most of the assays we needed had already been cleared by the [US Food and Drug Administration], and we had reassurances that by the time we were ready to go live [with clinical testing], the assays would be available commercially," he said.

With limited assay availability and some "inherent unknowns associated with implementing a new system," Ascend conducted a gradual implementation of the Atellica IM 1600.

Most of the immunoassay testing menu was approved and commercially available by November 2018. Two remaining low-volume assays — for prostate specific antigen and HIV antibody/antigen combo testing — became commercially available and were implemented at Ascend in early 2019.

The lab retained some XPT systems until all assays were available on the Atellica, but the gradual phase-in of the new testing system didn't impede turnaround times or have an impact on the lab's staff, its clients, or their patients, according to Fountaine.

By last summer, Ascend decided to implement the Atellica Solution and completed implementing the modules in March this year.

The new system enables a longer walkaway time than its predecessor. On average, the Atellica immunoassay module has a walkaway time of roughly four hours, Fountaine said. With the XPT, laboratorians needed to manually restock multiple consumables within two hours. Increased walkaway time was enabled by the new system's increased storage of cuvettes, sample tips, and reagents, and increased cuvette and sample tip waste storage capacity.

"In such a large space every step counts, so having to intervene with the instrument less frequently is a big deal," Fountaine said.

Daily maintenance for the immunoassay systems was reduced from one hour to 30 minutes, and Ascend was able to schedule maintenance during low-volume periods so that it didn't interrupt testing. "Being an end-stage renal disease clinical reference lab … we are not like your typical hospital-based clinical laboratory that performs testing 24/7/365 and sees fluctuations in [its] testing throughout each day," Fountaine said. "For us, the bulk of our testing is typically performed within one shift and extends into a second shift during our busiest periods. A maintenance schedule during off-peak periods benefitted us most."

The lab also saw staffing improvements with the implementation of the Atellica, Fountaine said. The lab had maintained a lean staffing approach with the Advia system, and it was able to maintain that despite a doubling of testing volume with the Atellica. With increased time away from the machines, Ascend's staff has time to engage in other tasks, such as cross-training and providing support for administrative secondary activities.

Going forward, Ascend may add additional Atellica modules, but "at this time we have sufficient immunoassay analyzers," Fountaine said.

In general, lab managers are implementing advanced analyzers in response to economic and operational pressures, and next-generation integrated diagnostic systems, such as the Atellica, are among the most important drivers of growth within the largest diagnostic companies.

For example, Abbott's next-generation Alinity line of diagnostic analyzers is an increasingly important driver of its revenue growth, according to its CEO Myles White. Meanwhile, Roche Diagnostics' immunodiagnostics business, which grew 7 percent year over year in the most recent quarter, was the largest contributor to growth in the firm's Diagnostics division. 

The Atellica Solution, cleared for marketing by the US Food and Drug Administration in 2017, represents an important driver of growth for Siemens Healthineers, according to its CEO Bernd Montag. The overall system — used for the clinical analysis of body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion-selective electrode technology — consists of clinical chemistry and immunoassay analyzers.

The system is the firm's latest offering for testing laboratories, but it is also "the first incarnation of who we want to be and who we will be in lab diagnostics," Montag said during a presentation at the AACC event. The Atellica Solution is not only a product, he said, but an incarnation of the firm's philosophy, in which it wants "to bring lab diagnostics to the next level" by focusing on productivity, artificial intelligence, and modularity, among other objectives.